Trial Outcomes & Findings for Evaluation of a Single Use Point of Care Device for the Diagnosis of Respiratory Pathogens (NCT NCT04431050)

Results Overview

The primary outcome will be to review the feasibility and the diagnostic accuracy for viral respiratory pathogens in this novel device using fresh patients' samples in a real-life clinical setting compared to the standard diagnostic testing of a respiratory viral PCR in the laboratory and/or rapid flu swab (Cepheid, Sunnyvale, CA, USA) using sensitivity, specificity, positive predictive value and negative predictive values. A minimum of 50 devices will be tested with fresh patient samples in a real life clinical setting.

Recruitment status

TERMINATED

Target enrollment

6 participants

Primary outcome timeframe

through study completion, an average of 1.5 years

Results posted on

2025-02-13

Participant Flow

Participant milestones

Participant milestones
Measure	Suspected Influenza or Other Respiratory Viral Infection. Any adult presenting to the Accident \& Emergency department with influenza like illness or a febrile illness associated with symptoms such as cough, sore throat or rhinorrhoea, and for whom a respiratory viral screen is clinically indicated. For the purposes of this study one nasal swab will be taken from consenting adults. Point of care testing of respiratory viruses.: Single use point of care diagnostic device.
Overall Study STARTED	6
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Suspected Influenza or Other Respiratory Viral Infection. n=6 Participants Any adult presenting to the Accident \& Emergency department with influenza like illness or a febrile illness associated with symptoms such as cough, sore throat or rhinorrhoea, and for whom a respiratory viral screen is clinically indicated. For the purposes of this study one nasal swab will be taken from consenting adults. Point of care testing of respiratory viruses.: Single use point of care diagnostic device.
Age, Categorical <=18 years	0 Participants n=6 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=6 Participants
Age, Categorical >=65 years	2 Participants n=6 Participants
Sex: Female, Male Female	4 Participants n=6 Participants
Sex: Female, Male Male	2 Participants n=6 Participants
Region of Enrollment United Kingdom	6 participants n=6 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 1.5 years

Population: study terminated before results

The primary outcome will be to review the feasibility and the diagnostic accuracy for viral respiratory pathogens in this novel device using fresh patients' samples in a real-life clinical setting compared to the standard diagnostic testing of a respiratory viral PCR in the laboratory and/or rapid flu swab (Cepheid, Sunnyvale, CA, USA) using sensitivity, specificity, positive predictive value and negative predictive values. A minimum of 50 devices will be tested with fresh patient samples in a real life clinical setting.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: through study completion, an average of 1.5 years

Population: outcome measure data not collected

The secondary outcome will be to review the feasibility and the diagnostic accuracy for viral respiratory pathogens in this novel device using patients' stored samples in a laboratory setting compared to the standard diagnostic testing of a respiratory viral PCR in the laboratory and/or rapid flu swab (Cepheid, Sunnyvale, CA, USA) using sensitivity, specificity, positive predictive value and negative predictive values.

Outcome measures

Outcome data not reported

Adverse Events

Suspected Influenza or Other Respiratory Viral Infection.

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joan Nanan

Imperial

Phone: +44 (0)20 7594 9000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place